Eclampsia, Gestational Hypertension, HELLP Syndrome, Postpartum Hypertension, Preeclampsia, Pregnancy-Associated Hypertension, Stage 2 Hypertension
Conditions
Keywords
Community health worker, Postpartum, Blood pressure, Self-measured blood pressure monitoring, Cardiovascular disease prevention, Life's Essential 8, Hypertensive disorders of pregnancy, Alabama, Primary care linkage
Brief summary
High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care. A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support. The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.
Detailed description
This is a single-site, two-arm, parallel, randomized controlled efficacy trial conducted at the University of Alabama at Birmingham (UAB), building on the Alabama Womb to Heart Solution (AW2H) feasibility/acceptability pilot (NCT06353256, N=61). Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count \[HELLP\] syndrome) or stage 2 hypertension (systolic blood pressure \[SBP\] \>=140 mmHg or diastolic blood pressure \[DBP\] \>=90 mmHg) are randomized 1:1 to usual care or usual care plus a 6-month community health worker (CHW) intervention delivered in partnership with ConnectionHealth. Usual care (both arms) includes brief self-measured blood pressure education, a pregnancy-validated iHealth blood pressure (BP) Cuff Kit (provided through partnership with the Preeclampsia Foundation), and written education on hypertensive disorders of pregnancy and long-term cardiovascular risk. The CHW intervention adds visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual), covering home BP monitoring coaching with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, medication adherence, postpartum and pediatric visit reminders, breastfeeding and contraception counseling, Life's Essential 8 behavior coaching, primary care linkage, mother-baby education, and trauma-informed emotional support. The primary outcome is mean systolic blood pressure at 6 months post-enrollment (mean of 3 readings taken 1 minute apart with the validated iHealth monitor, following a protocol adapted from the Chronic Hypertension and Pregnancy (CHAP) Maternal Follow-up Study). The trial provides 80% power to detect a 7 mmHg difference in SBP (standard deviation \[SD\] 14.5, two-sided alpha=0.05) with 138 participants; enrollment of 174 allows for 20% attrition. Analysis follows intent-to-treat principles. Aim 2 comprises qualitative interviews (up to 20 intervention-arm participants) and two focus groups (CHWs/ConnectionHealth leadership; healthcare providers) analyzed thematically to inform future implementation.
Interventions
Six-month community health worker (CHW) program delivered in partnership with ConnectionHealth. Visit/contact frequency: Approximately 2 times/week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26; visits may be in person or virtual (phone/video). CHWs coach home blood pressure monitoring with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, reinforce antihypertensive medication adherence, educate on postpartum danger signs and long-term cardiovascular risk, remind about postpartum and pediatric visits, counsel on breastfeeding and contraception, coach on American Heart Association (AHA) Life's Essential 8 behaviors, assist with scheduling and attending a primary care appointment, provide mother-baby guidance (safe sleep, immunizations, developmental milestones), and offer trauma-informed emotional support.
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth blood pressure (BP) Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term cardiovascular disease (CVD) risk, and postpartum danger signs.
Sponsors
Study design
Masking description
Participants and community health workers cannot be masked. The primary outcome is device-measured under a standardized protocol observed by a research coordinator.
Intervention model description
Two-arm, parallel, randomized controlled trial; 1:1 allocation to usual care or usual care plus a 6-month community health worker intervention.
Eligibility
Inclusion criteria
* Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count \[HELLP\] syndrome) or stage 2 hypertension per American College of Cardiology/American Heart Association (ACC/AHA) guidelines (systolic blood pressure \[SBP\] \>=140 mmHg or diastolic blood pressure \[DBP\] \>=90 mmHg) on two separate occasions at delivery-related hospital discharge or during the postpartum period * Delivered in the last six weeks at \>=14 weeks gestational age, including pregnancy loss * 16-56 years old * Speaks and writes in English * Delivering at University of Alabama at Birmingham (UAB) Hospital
Exclusion criteria
* Declines randomization * Does not speak English * Currently incarcerated * Currently enrolled in other community health worker studies or services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | 6 months post-enrollment | Mean systolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using a pregnancy-validated iHealth home blood pressure monitor, following a standardized measurement protocol during an in-person or coordinator-observed virtual visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure (DBP) | 6 months post-enrollment | Mean diastolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using the same standardized protocol as the primary outcome. |
| Scheduling of a Primary Care Visit | By 6 months post-enrollment | Proportion of participants with integration into primary care, defined as participant self-report of a scheduled primary care visit. |
Countries
United States
Contacts
University of Alabama at Birmingham